Covance

Associate Data Project Manager

Company
Covance
Location
Belgium
Salary
Competitive
Posted
10 Jun 2021
Closes
12 Jun 2021
Ref
10024_63512-belgium
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Joining Covance Flexible Solutions (FSPx) will offer a rewarding career, a chance to work in an energetic & team-oriented workplace, and access to competitive benefits. With the support of exceptional people from across the globe and a vast array of career options, you'll be empowered to own your career journey with mentoring, training and personalized development planning.

Our unique opportunity will allow you to bring your specialized discipline to a core team outsourced to a world class leading global healthcare company. Dedicated to our Client 100% of the time, you will play a key role in the drug development cycle and see a product through to launch with the support of both a dedicated Covance line manager and our client project teams.

Your role:

The Associate Data Project Manager role is a great opportunity to work within our sponsor dedicated department and have this unique relationship with a sponsor. Homebased in Europe.
  • Collaborate with respective project sponsor and stakeholders to develop effective project plans to include scope, goals, deliverables, required resources, risks, issues and milestone timing.
  • Effectively plan and execute multiple Data Management projects simultaneously
  • Assign tasks and responsibilities within Data Management to team members, in a manner that: optimizes team capability; delivers timely and accurate results; and supports the needs of the business
  • Ensure that assigned team executes Data Management functions in accordance with Covance and/or sponsor Standard Operating Procedures (SOPs)
  • Serve as Data Management Lead on selected projects
  • Create study specific Data Management Plans (DMPs)
  • Provide input, assistance and/or oversight with preparation of edit check specifications for a specific project, Data entry guidelines preparation, Case Report Form design and associated specification
  • Oversee and contribute to creation of test data for entry screens and edit checks
  • Serve as primary contact for DM with all relevant parties including but not limited to Clinical Operations and Sponsor, informing stakeholders if there is a need to deviate from project scope or plan
  • Manage sponsor relationships and triage issues as appropriate
  • Ensure that project team member performance supports project budget and delivery requirements
  • Participate in and/or contribute to Sponsor and/or Regulatory audits/inspections
  • Participate/attend Sponsor requested meetings as required
  • Perform other duties as required by the Department
  • Education/Qualifications:
    University degree in Medical/Life Science/Computer Science
    Experience:
    • Ability to maintain confidentiality of data and information during interactions with staff at all levels

    • Prior experience in Data Management in the pharmaceutical, biotechnology, medical device/diagnostics or clinical trial industries.

    • Effective communication skills

    • Working experience with Medidata Rave, Inform and Oracle Clinical is preferred

    • Strong leadership qualities and experience of supervising other Data Managers

    • Hands on experience with EDC systems

    • Good knowledge of the drug development life cycle

    • Understanding of the principles of ICH GCP and regulatory requirements

    • Good computer literacy with working knowledge of Windows and Microsoft Office applications

    • Good oral and written communication, organisational skills and personal presentation

    • The ability to communicate effectively in English

    • Experience working within a team environment under time and resource pressures

    • Proven experience in clinical trials with knowledge of SOPs, regulatory reporting requirements and accepted practices

    • Confident dealing with external and internal clients and providers

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